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Gilead (GILD) Announces Positive New Data on Breast Cancer Drug
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Gilead Sciences, Inc. (GILD - Free Report) has announced positive new data from a post hoc subgroup analysis from the phase III TROPiCS-02 study evaluating the breast cancer drug Trodelvy (sacituzumab govitecan-hziy).
Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate.
The study evaluated Trodelvy versus comparator chemotherapies (physicians’ choice of chemotherapy, TPC) in patients with HR+/HER2- metastatic breast cancer who progressed on endocrine-based therapies and at least two chemotherapies. The analysis examined progression-free survival (PFS) in the intention-to-treat population by HER2-immunohistochemistry (IHC) status.
Results showed Trodelvy’s efficacy across HER2-low and IHC0 status in pre-treated metastatic breast cancer patients. Trodelvy improved median PFS vs. TPC in both HER2-low (IHC1+ and IHC2+/ISH-negative) and IHC0 groups.
Trodelvy is not approved by any regulatory agency for the treatment of HR+/HER2- metastatic breast cancer. Its safety and efficacy have not been established for this indication. Gilead has submitted a supplemental biologics license application (sBLA) to the FDA based on data from TROPiCS-02.
It is approved in multiple countries for treating adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
The drug is also approved in the United States under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Gilead’s stock has lost 12.1% so far in the year compared with the industry's decline of 24.7%.
Image Source: Zacks Investment Research
Gilead is making efforts to develop its oncology business to diversify its revenue base. The oncology space is lucrative but saturated as well.
While the HIV business maintains momentum on the back of Biktarvy and approval of new treatments, competition is stiff in the HIV business from the likes of GSK plc (GSK - Free Report) .
Gilead’s HIV treatment lenacapavir has been recently approved by the European Commission under the brand name Sunlenca for treating HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
Most anti-virals act on just one stage of viral replication while Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross-resistance to other existing drug classes.
GSK’s HIV franchise recorded 7% growth in the second quarter. Growth was driven by new HIV products Dovato, Cabenuva, Rukobia, Juluca and Apretude, and a favorable U.S. pricing mix.
Loss estimates for BOLT have narrowed to $2.54 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.
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Gilead (GILD) Announces Positive New Data on Breast Cancer Drug
Gilead Sciences, Inc. (GILD - Free Report) has announced positive new data from a post hoc subgroup analysis from the phase III TROPiCS-02 study evaluating the breast cancer drug Trodelvy (sacituzumab govitecan-hziy).
Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate.
The study evaluated Trodelvy versus comparator chemotherapies (physicians’ choice of chemotherapy, TPC) in patients with HR+/HER2- metastatic breast cancer who progressed on endocrine-based therapies and at least two chemotherapies. The analysis examined progression-free survival (PFS) in the intention-to-treat population by HER2-immunohistochemistry (IHC) status.
Results showed Trodelvy’s efficacy across HER2-low and IHC0 status in pre-treated metastatic breast cancer patients. Trodelvy improved median PFS vs. TPC in both HER2-low (IHC1+ and IHC2+/ISH-negative) and IHC0 groups.
Trodelvy is not approved by any regulatory agency for the treatment of HR+/HER2- metastatic breast cancer. Its safety and efficacy have not been established for this indication. Gilead has submitted a supplemental biologics license application (sBLA) to the FDA based on data from TROPiCS-02.
It is approved in multiple countries for treating adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
The drug is also approved in the United States under the accelerated approval pathway for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Gilead’s stock has lost 12.1% so far in the year compared with the industry's decline of 24.7%.
Image Source: Zacks Investment Research
Gilead is making efforts to develop its oncology business to diversify its revenue base. The oncology space is lucrative but saturated as well.
While the HIV business maintains momentum on the back of Biktarvy and approval of new treatments, competition is stiff in the HIV business from the likes of GSK plc (GSK - Free Report) .
Gilead’s HIV treatment lenacapavir has been recently approved by the European Commission under the brand name Sunlenca for treating HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
Most anti-virals act on just one stage of viral replication while Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross-resistance to other existing drug classes.
GSK’s HIV franchise recorded 7% growth in the second quarter. Growth was driven by new HIV products Dovato, Cabenuva, Rukobia, Juluca and Apretude, and a favorable U.S. pricing mix.
Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the sector are Bolt Pharmaceuticals (BOLT - Free Report) and Dynavax (DVAX - Free Report) . Both carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.54 from $2.87 in the past 60 days. BOLT surpassed earnings in three of the trailing four quarters, the average being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.